Monthly Archives: May 2018

The Research 411 Portal is the place to get answers to your questions about how to navigate the conduct of research throughout the MSHS. It is a help desk ticketing system where you can ask general questions through Research 411 or get help with the services that the Office of Research Services (ORS) offers. See the below menu of services offered. The ORS team is dedicated to helping researchers navigate the expanding research enterprise of the MSHS.

TIP: If you’re not sure which ticket to use, or if there isn’t a ticket for your specific questions, use the general Research 411 form at the top of the list of choices.

New services are continually added as the research enterprise continues to evolve. Announcements about new services will be made via the ISMMS Research Listserv. Please make sure that you are subscribed by entering your email address under “Research Listserv” on the Research Web Portal’s Getting Started page (within the MSHS firewall) to ensure you stay informed.

The Translational and Molecular Imaging Institute (TMII) is pleased to provide a recap of the 8th Annual TMII Symposium.

We applaud all the fantastic talks by the invited speakers, oral presentations selected from submitted abstracts and poster presenters. In case you missed it, we would like to announce the winners of the best poster from each section:

Cancer/Body: Stefanie Hectors “MRI Texture Features as Predictors of Histopathologic and Genomic Characteristics of Hepatocellular Carcinoma”

Neuroimaging: Laurel Morris “Enhanced signal power with high field MRI improves power for detection of signal in small midbrain and subcortical structures relevant for psychiatric research”

You can find the program for the symposium and for the Windows to Our Body Art Exhibition at the same link https://tmii.mssm.edu/tmii2018/.
Please visit the Windows to Our Body Art Exhibition at The Grady Alexis Gallery at El Taller (215 E99th St.). The gallery has extended the exhibition to May 30th.

The Icahn School of Medicine at Mount Sinai and Mount Sinai Innovation Partners has announced the launch of the i3 Asset Accelerator, a new fund that fast-tracks select research discoveries to reach patients sooner, and has selected its first two projects to receive funding in 2018. Read more about i3 and view photos from the launch event.

All human subjects research being reviewed by an external IRB, through either a master reliance agreement with a commercial IRB, the SMART IRB Reliance Agreement, or through study-specific reliance agreements with other institutions, must submit a Request to Rely (R2R) to the PPHS office through Ideate for registration and review of local requirements (e.g. conflict of interest, education requirements, state law, institutional policy, auxiliary office review).

Forms required by the external IRB (e.g. agreements, waiver of jurisdiction forms, local context forms) will not be completed prior to a submission in Ideate. While each external IRB may have specific requirements, the use of any external IRB by Mount Sinai researchers should follow the general process outlined below.

Please note that research activities cannot begin at any Mount Sinai location until acknowledgment of this registration has been provided, even if the external IRB has provided their review/approval of the protocol.

Continuations: All ongoing research must renew the R2R, prior to the expiration date issued by the reviewing IRB, by making a Continuation submission once continuing review approval from the IRB of record has been obtained. Once the approval from the external IRB has been submitted to the PPHS, it is not required that research activities stop until an acknowledgement is processed; however, it is possible that modifications may be required based on local requirements.

For requests made through Ideate, create a continuing review application and upload the current IRB approval documents and copies of the most recent protocol and/or consent forms if any changes have been made

If the initial request was made outside of Ideate, a copy of IRB approval must be submitted to IRB@mssm.edu with HSM# – External IRB Continuation in the subject line. The body of the email should include the following:

Current study status (e.g. open to enrollment, open for data analysis only)

The new IF# for all financial conflict of interest disclosures in Sinai Central

A statement regarding whether there have been any changes in research personnel over the past year.

A statement regarding whether there have been any changes to the protocol that would require additional local review (e.g. addition of radiation exposure, changes to required consent form language, changes in PI)

Copies of the most recent protocol and/or consent forms if any changes have been made (regardless of whether the changes affect local review)

GCO# and confirmation that an annual submission to GCO has been made in InfoEd

Please contact the PPHS Office at 212-824-8200 or IRB@mssm.edu with questions about the Request to Rely (R2R) requirements.

Excerpt from NIH Notice(NOT-OD-18-179)
NIH has developed a new Human Subjects System (HSS), which consolidates human subjects and clinical trial information in one place.

Information captured in HSS is generally submitted on the PHS Human Subjects and Clinical Trials Information form in application packages submitted for due dates January 25, 2018 or later and Research Progress Performance Reports (RPPR).

Post-submission updates to human subjects and clinical trial-related information (including human subjects protections, participant and enrollment information, and Clinicaltrials.gov registration and reporting information) must be made in HSS via the eRA Commons Status page after June 9, 2018.

HSS will replace the Inclusion Management System (IMS), used for reporting participant sex/gender, race, and ethnicity information. The Inclusion link will no longer appear on the Commons Status page as of June 9, 2018.

As of January 17th, 2018 the new NIH penalties for non-compliance with Clinicaltrials.gov registration and reporting went into effect. The potential penalties are financial, at over $11,000 per day of non-compliance, and may impact continued funding of both existing and future NIH awards.

What you need to know to achieve compliance:

Understanding the Date & Deadline requirements

When registering a study in ClinicalTrials.gov, specific dates must be provided – if the PI is uncertain about an exact date, the best anticipated date must be provided until an actual date is available. Dates cannot be left blank.

In some cases the primary completion date and study completion dates are the same.

In other cases, the primary outcome measures may be collected much earlier than the secondary. And yes, results for the primary outcome measure must be posted within 1 year of this date.

Other deadlines to remember –

Records must be updated every 12 months.

Records must be updated within 30 days of Recruitment Status changes or amendments that affect information in ClinicalTrials.gov record, especially recruitment status, location and contact information.

Records must be updated within 30 days after the completion date (last data collection).

After initial submission of registration data, the ClinicalTrials.gov Quality Assurance team may respond with queries. The PI has to respond within 15 days(yes, this includes weekends).

After initial submission of Results, the ClinicalTrials.gov Quality Assurance team may respond with queries. The PI has to respond within 30 days.

All unmet dates and deadlines trigger errors in ClinicalTrials.gov and a status of “non-compliance” in ClinicalTrials.gov.

Do you conduct research, or would like you like to be involved in research within the Mount Sinai Health System (MSHS)?

Are you seeking funding for your next big idea?

Would you like to keep up-to-date about research administration policies and procedures at Icahn School at Mount Sinai?

The Research Listserv can help.

The Research Listserv is one single email list encompassing the entire research community. If you do research at MSHS, you may already be a member of the Research Listserv. To check if you are a member or to change your subscription preferences, click here and enter your email address under Research Listserv at any time within the MSHS firewall (on-site at a MSHS location or via VPN). If you are not a member, your email selections will be blank. To join, or edit your existing preferences, choose your topics and click at the bottom of the page. You will receive an email confirming your subscription or any changes you make.

You will be able to choose from the following:

Not convinced? Maybe this will help –

You can modify your subscriptions at any time by entering your email address under Research Listserv on the Research Portal Getting Started page, when you are within the MSHS firewall. You will always receive a confirmation email when you change your subscription preferences.

You can unsubscribe from everything, and still be assured that you will receive messages intended for the entire research community (Dean’s Office or the most important messages from the GCO, IRB/PPHS, IACUC, etc.).

You will receive each mailing ONLY ONCE, unless you are subscribed with two functional email addresses. If that should happen, please submit a Communication Support Request for assistance with this process.

If you are part of the research community of the Mount Sinai Health System, you should be a part of the Research Listserv. Join today!